Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease
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ClinicalTrials.gov Identifier: NCT00892450 |
Recruitment Status
:
Completed
First Posted
: May 4, 2009
Last Update Posted
: October 3, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson's Disease Overactive Bladder | Drug: Oxybutynin and darifenacin | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease: A Randomized, Double-blind, Crossover Pilot Study |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | September 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1
crossover design
|
Drug: Oxybutynin and darifenacin
Participants with overactive bladder will take each medication for 4 weeks.
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- compare cognitive side effects [ Time Frame: 10 weeks ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of idiopathic PD (ICD9=332.0)
- MMSE 24, able to give informed consent and complete questionnaires and voiding diaries.
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Urological work-up within 3 months of enrollment to:
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Rule out treatable causes of urinary symptoms
- Urinalysis (UA)
- Post-void residual ultrasound (PVR)
- Urinary cytology
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Documented symptoms OAB on screening 3-day voiding diary:
- Average of 1 urgency episode / 24 hours, and
- Average of 8 micturitions / 24 hours
- Subjective complaints of symptoms for 3 months
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Exclusion Criteria:
- Exposure to anticholinergics or antispasmodics within the last 4 weeks (among them: atropine, tolterodine, benztropine, trihexyphenidyl, dicyclomine, hyoscyamine, and scopolamine)
- Exposure to drugs with known effects on cognition (i.e. opioids, benzodiazepines or sedating antihistamines) within the last week
- Exposure to drugs contraindicated or cautioned in use with the 2 study medications (drugs that also use the cytochrome P450 enzyme, primarily CYP3A4). These include: ketoconazole, itraconazole, miconazole, erythromycin, clarithromycin, ritonavir, nelfinavir, nefazodone, flecainide, thioridazine and tricyclic antidepressants.
- Nonpharmacological treatment of OAB within the last 4 weeks (for example: biofeedback, physical therapy, acupuncture)
- Uncontrolled narrow angle glaucoma
- History of gastric or urinary retention / dysmotility (ulcerative colitis, myasthenia gravis and severe constipation)
- History of hepatic or renal impairment
- History of severe gastro-esophageal reflux disease and/or use of bisphosphonates, patients at risk for esophagitis
- Previous exposure to anticholinergic for OAB symptoms that resulted in side effects that caused cessation of the medication

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00892450
United States, Pennsylvania | |
VA Medical Center, Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Jayne R Wilkinson, MD | VA Medical Center, Philadelphia |
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT00892450 History of Changes |
Other Study ID Numbers: |
01143 |
First Posted: | May 4, 2009 Key Record Dates |
Last Update Posted: | October 3, 2014 |
Last Verified: | October 2014 |
Keywords provided by VA Office of Research and Development:
Overactive bladder symptoms Parkinson's disease darifenacin oxybutynin cognition |
Additional relevant MeSH terms:
Parkinson Disease Urinary Bladder, Overactive Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Urinary Bladder Diseases Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations |
Signs and Symptoms Oxybutynin Darifenacin Cholinergic Antagonists Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Urological Agents |